Tuesday, May 12, 2020

Does Your China-Made Masks Truly Protect You? Knowing the Real Numbers that Matter

With many places starting to open their business back up, one might think that our situation in the pandemic is getting better. With social distancing, masks, and the proper protective precautions, we are on a better route than what was previously predicted. Without proper precautions however, reopening business can be disastrous in spreading COVID-19 and creating a second peak. Hence, it is important to continue using masks. 

It is an easily definable issue when one is unable to get the PPEs to protect themselves. It is another more difficult to define issue when one buys PPEs that do not actually protect them. There is a huge market for masks, with China being the main supplier. But not every mask is created equally: some are high quality and others work worse than a scarf. With all the popularity of masks and respirators (strictly speaking, N95 and KN95 are in fact respirators, we use “masks” as a broad term for simplicity), people are throwing out labels such as “N95, KN95...etc”, expecting to understand the masks by these tags alone. But these labels don’t tell the complete story: In order to keep your eyes open, It is important to understand another foreign classification: GB19083 and GB2626 (GB” is the abbreviation for National Standard in Chinese language (pinyin “Guo Biao”)). 

Why the Most Protective GB19083 Sterilized Medical N95 Mask is More Expensive than KN95

During the start of the pandemic in Wuhan, Wuhan's frontline protective equipment was tight, and many hospitals issued an “accepting donation announcement" for PPEs. If you look into those announcements carefully, you will find that almost all hospitals were very clear that among the protective equipments they need (such as medical goggles and protective suits), the medical protective respirators they were seeking help with were required to comply withGB19083-2010 specifically, not GB2626-2006 / 2019! If GB2626 can really completely replace GB19083-level medical masks, why were the hospitals being so picky in a critical time of need?



GB19083 is the Chinese national standard for surgical N95 respirator.


It is important to understand the difference between these two classifications

  1. Class 1 masks conforming to GB19083 can achieve 95% filterability and prevent liquid penetration: allowing them to be used for various operations in medical institutions. N95 is just an oral statement for everyone (from NIOSH taxonomy in the US). It is the aforementioned medical protective mask: the material of the outer surface of the mask has the ability to block pressure body fluid from splashing and penetrating.
  2. While the KN95 (typically non-medical usage before the pandemic) protective face cover is great mask to protect against airborne particulates and hazards, having the same efficiency rate of at least 95% of airborne particles > 0.3 microns, the KN masks conforming to GB2626 cannot guarantee that the mask will not be wet and cannot be used for medical operations, especially high-risk operations such as tracheotomy and tracheal intubation. These masks can be used in low risk situations but should NOT be used by personnel dealing directly with patients under normal situations.

In fact, even when the most classic masks imported by 3M (such as 1860 and 9132) enter China for sale, they must obtain a medical device registration certificate from China in accordance with the medical device management requirements.  To get the medical device registration certificate, the mask must be tested according to the requirements of GB19083-2010. After passing the test, this technical standard will be printed on the outer packaging. In fact, similar to how the NIOSH certification is required for medical N95s in the US, this country-specific standard created a huge barrier when people tried to donate 3M masks to China.    

Success of the civilian KN95 over the medical sterile N95: One Third of the Cost, Similar Price Range 

When you get yourself a GB19083 sterile mask, you can have confidence that the mask is of good quality. China is extremely strict with counterfeit certifications for its own masks and these masks are expected to be used by their top hospitals and doctors. Hence these masks are harder to come by and are more expensive to import (costs and shipping can be higher than $7, some selling online over $10 or $11 even at bulk!)

With GB2626-2006/2019, the requirement is being a “Respiratory protection—Non-powered air-purifying particulate respirator”. There is no protection from fluids and these are made for civilians. These masks also tend to be good quality to follow the certifications of their own government. 

On April 3, 2020, the FDA issued an emergency use authorization for KN95 masks. The CDC relaxed the requirements and listed KN95 masks (quality ones would meet GB2626 standards) as a suitable alternative WHEN (medical) N95s are not available. This relaxation has led to a different problem: We do have real medical sterile N95s right in front of our customers, yet customers sourcing for healthcare workers or claim to donate to hospitals still knowingly choose the KN95s since they think they are better value or that it allows them to brag about more "N95"s donated based on the budget at hand. 

When there are no domestic certifications, there is a huge risk to receiving low quality products. While they can have KN95, N95, or FFP2 attached to their name, they may be of poor quality: filtering as much as a piece of cloth. Hence the price on these masks can be extremely cheap, especially for the ones without quality control.

Focusing on the Right Keywords

If you are looking for surgical grade sterile N95 masks and other high quality PPEs, visit our website at www.Herbal-Pal.org. We have FDA and CE certified surgical N95 respirators that meet the GB19083 standards, as well as FFP2s and disposable masks for civilian usage, medical isolation goggles, isolation gowns, and medical protective suits to keep you safe.


References:

“Possible Alternatives to Surgical Filtering Facepiece Respirators: Healthcare.” Retrieved from https://multimedia.3m.com/mws/media/1803705O/possible-alternatives-to-surgical-filtering-facepiece-respirators-healthcare.pdf

“F.D.A. to Allow Use of KN95 Masks Approved by China”. Retrieved from https://www.nytimes.com/2020/04/03/health/coronavirus-n95-kn95-masks.html

“The Difference between GB2626 and GB19083” in Chinese. “口罩国标GB2626和GB19083区别” https://zhuanlan.zhihu.com/p/113473414

Whitelist in Chinese: Ministry of Commerce of the P.R.China. China Ministry of Commerce, General Administration of Customs, The National Medical Products Administration (NMPA, formerly the China Food and Drug Administration, or CFDA) Regulation Year 2020 Notice #5 on Export of Medical Supplies”. Published March 31, 2020.

China Whitelisted Medical Device Makers for Respirators: 中国商务部公布的医疗器械械字号白名单, highlighted in Chinese is the manufacturer of medical protective masks meeting GB19083 standards, Henan Success Technology.

Difference between N95, KN95, and FFP2 in Chinese. “N95、KN95、FFP2口罩到底是啥?和医用口罩区别在哪?—口罩标准告诉你” Retrieved from https://www.cnis.ac.cn/bydt/kydt/202002/t20200212_49303.html

“Those are critical supplies that must continue to be reserved for health care workers and other medical first responders” Retrieved from
https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-and-surgical-masks-face-masks#s1

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